Effective biomarker testing rates in a large U.S. community practice.
Authors: Lucio N. Gordan, Michael Diaz, Anjan Jayantilal Patel, Matthew A. Fink, David Wenk, Alison Roos, Yuqiu Jiang, Janice Tam, Pratheesh Sathyan, Phillip G. Febbo
Journal: Journal of Clinical Oncology (2022)

e21093 Background: Molecular testing is an integral part of care for patients with non-small cell lung cancer (NSCLC). Professional guidelines advise broad molecular profiling to identify driver mutations that have either FDA approved therapies or available clinical trials. Testing is recommended for at least 8 biomarkers plus PD-L1 immunohistochemistry and obtaining biomarker testing results back before initiation of treatment is critical. However, many patients with NSCLC remain untested or receive inadequate treatment prior to obtaining a test result. We performed a retrospective chart review to assess real world effective biomarker testing rates and practice patterns to understand the current biomarker testing scenario in a large US community practice, Florida Cancer Specialists (FCS). Methods: Advanced NSCLC patients (Stage IV; n = 361) who received care in the FCS network and were diagnosed or received first-line treatment on or after 1/1/2020 were included in this retrospective observational study. Data was extracted from the electronic medical records in participating practices as well as via abstraction of patient records when available. Patient-level data was anonymized and reported in aggregate. All data collected for this analysis was evaluated in accordance with regulatory requirements and applicable guidance for electronic records. We determined the percentage of biomarkers tested, orders placed and received before treatment, test ordered after treatment, and the overall effective testing rate, defined as orders placed and result received before treatment start/stage IV patients treated. Results: The median patient age was 70 years (range, 41-90), 188 (52%) were male, and 277 (77%) were Caucasian. 270 (75%), had adenocarcinoma histology, and 273 (76%) had an ECOG status of 0 or 1. Biomarker testing was ordered for 285 patients (79%). EGFR tests were more likely to be ordered before the start of treatment than other biomarkers. The median time between biomarker test ordering to treatment start was 15 days. 217 patients received test results before treatment start (effective testing rate = 60%). 6% of patients had tests ordered later in their workup, while 13% had tests ordered early, but received test results after treatment start. 21% of patients were not tested for any biomarker. 85% of stage IV patients tested received multi-gene tests. 71% of patients had PD-L1 testing and less than 2% received PD-L1 testing alone. Conclusions: This real-world study showed that 85% stage IV NSCLC patients in a large US community practice network underwent multigene biomarker testing and 60% received their test results prior to treatment start. The median time between biomarker test ordering to treatment start was 15 days. Strategies to improve time to biomarker test order, enhance percentage of patients tested, and improvement of percentage of patients with test results prior to initiation of therapy are ongoing.